Effects of a protein ‘preload’ on glycaemia and gastric emptying over 4 weeks in patients with type 2 diabetes

Phase 2

Completed

• Conditions: Type 2 diabetes; Diet and Nutrition - Other diet and nutrition disorders; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12614000831684
• Lead Sponsor: niversity of Adelaide

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-08-05
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

Patients with type 2 diabetes managed by diet alone

Exclusion Criteria

1.Significant medical disorders (other than diabetes);
2.Significant gastrointestinal symptoms or history of gastrointestinal surgery (other than appendicectomy or cholecystectomy);
3.Intake of >20 g alcohol on a daily basis or cigarette smoking;
4.Current use of medications which may affect gastrointestinal function or appetite (e.g. prokinetic drugs, orlistat, tricyclic antidepressants);
5.Current pregnancy or lactation;
6.Inability to prepare meals, or meet dietary requirements, (including frequent dining out (>2x/week)) and widely fluctuating exercise patterns;
7.Inability or unwillingness to perform capillary blood glucose monitoring;
8.Exposure to radiation as part of a research study in the preceding 12 months.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Postprandial blood glucose concentrations following a potato meal taken at the beginning and end of 4 weeks intervention.[0, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 210 and 240 min after the meal]

Secondary Outcome Measures

Name	Time	Method
Gastric emptying of a potato meal taken at the beginning and end of 4 weeks intervention, measured by scintigraphy.[Images taken every 15 min after the meal for 240 min.];Fructosamine concentration in serum[Measured at the beginning and end of the active and placebo intervention periods.];Glycated haemoglobin in serum[Measured at the beginning and end of the active and placebo intervention periods.]